An interventional study of Microbiological analysis in Pulmonary Infiltrate New, sponsored by Northside Hospital, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by Northside Hospital, Inc. · Not applicable, Interventional, and Treatment
Pulmonary infiltrates frequently complicate the care of hematopoietic stem cell transplant (HSCT) and leukemia patients. Bronchoalveolar lavage (BAL) is frequently used to evaluate new pulmonary infiltrates in this population, however utility is limited by a historically low diagnostic yield for infection.
In an effort to improve diagnostic yields, this study will complete a Fiberoptic Bronchoscopy (FOB) within 8 hours of radiographic documentation of pulmonary infiltrates, prior to initiating new antibiotic therapy. To further improve detection of microbiological pathogens, the study will utilize PCR testing with rapid turnaround time to detect atypical pneumonia (M pneumoniae, C. Pneumonia, Legionella species, and respiratory viruses) and aspergillosis.
Proper diagnosis and prompt treatment favorably impacts survival in the post transplant setting, but is often difficult and frequently results in inappropriate or late therapy. Low yields may be linked with empiric antibody therapy begun prior to the procedure, delayed time to procedure, procedure technique, the presence of graft versus host disease (GVHD), neutropenia, and diffuse infiltrates (as opposed to localized infiltrates or focal masses and nodules). One recent study found that early FOBs (less than or equal to 4 days between detection of pulmonary infiltrates and FOB) were 2.5 times more likely to establish a diagnosis of pneumonia compared to late examinations. Delaying this procedure(greater than 5 days between detection of pulmonary infiltrates and FOB) was associated with drug resistant organisms, polymicrobial infections, and worsened patient prognosis.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 49 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Northside Hospital, Inc. is the lead sponsor of 27 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All patients will receive the lab testing on bronchoscopy specimens
Other: Microbiological analysis
Bronchoalveolar lavage (BAL) with subsequent testing for pathogens
Number of Patients With Positive Culture or Molecular Results After Brochoscopy
To determine the diagnostic yield related to fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in hematopoietic stem cell transplant (HSCT) and leukemia patients with acute respiratory symptoms and pulmonary infiltrates utilizing both current standard of care microbiology testing and emerging molecular genetic laboratory assessments.
Time frame: 30 days
Number of Patients With Positive CT Result
To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings. Patients were evaluated by changes on the CT and categorized as follows: 1. Air space 2. ground glass/reticular nodular 3. nodular/cavitary 4. single patchy infiltrate
Time frame: 30 days
Number of Participants With Positive Bacterial Results by PCR
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
Time frame: 24-48 hours
Number of Patients With Positive Fungal Results by PCR
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
Time frame: 24-48 hours
Number of Participants With Positive Viral Results by PCR
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
Time frame: 24-48 hours
Number of Participants With Positive Myocbacteria Results by Culture
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
Time frame: 24-48 hours
Recruitment period - May 2011 - Sept 2015 Patients were identified in either the outpatient clinic or inpatient BMT/Leukemia unit
| Milestone | Laboratory Testing |
|---|---|
| Started | 49 |
| Completed | 49 |
| Not completed | 0 |
To determine the diagnostic yield related to fiberoptic bronchoscopy (FOB) with bronchoalveolar lavage (BAL) in hematopoietic stem cell transplant (HSCT) and leukemia patients with acute respiratory symptoms and pulmonary infiltrates utilizing both current standard of care microbiology testing and emerging molecular genetic laboratory assessments.
| participants | All Patients Will Receive Lab Testing on Bronchoscopy Specimen |
|---|---|
| Number of Patients With Positive Culture or Molecular Results After Brochoscopy | 40 |
To correlate specific types of pulmonary infiltrates (focal, multifocal, or diffuse interstitial or alveolar infiltrates) with microbiological findings. Patients were evaluated by changes on the CT and categorized as follows: 1. Air space 2. ground glass/reticular nodular 3. nodular/cavitary 4. single patchy infiltrate
| participants | Laboratory Testing |
|---|---|
| Number of Patients With Positive CT Result | 49 |
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
| participants | Laboratory Testing |
|---|---|
| Number of Participants With Positive Bacterial Results by PCR | 2 |
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
| participants | Laboratory Testing |
|---|---|
| Number of Patients With Positive Fungal Results by PCR | 4 |
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
| participants | Laboratory Testing |
|---|---|
| Number of Participants With Positive Viral Results by PCR | 48 |
To describe the microbiological findings in HSCT and leukemia patients with fever, respiratory symptoms, and pulmonary infiltrates
| participants | Laboratory Testing |
|---|---|
| Number of Participants With Positive Myocbacteria Results by Culture | 2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Laboratory Testing | — | 0/49 (0%) | 0/49 (0%) |
| Age, Categorical(Participants) | Laboratory Testing |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 36 |
| >=65 years | 13 |
| Sex: Female, Male(Participants) | Laboratory Testing |
|---|---|
| Female | 18 |
| Male | 31 |
| Ethnicity (NIH/OMB)(Participants) | Laboratory Testing |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 46 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Laboratory Testing |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 39 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Laboratory Testing |
|---|---|
| United States | 49 |
Plan to share: No
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Northside Hospital, Inc.